TEMOMEDAC 5 mg Hard Capsules

Зміст інструкції

1. Temomedac 5 mg hard capsules, 20 mg hard capsules, 100 mg hard capsules, 140 mg hard capsules, 180 mg hard capsules, 250 mg hard capsules
   1. What is Temomedac and what is it used for
   2. What you need to know before taking Temomedac
   3. How to take Temomedac
   4. Possible side effects
   5. How to store Temomedac
   6. Package Contents and Other Information

Temomedac 5 mg hard capsules, 20 mg hard capsules, 100 mg hard capsules, 140 mg hard capsules, 180 mg hard capsules, 250 mg hard capsules

temozolomide

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Temomedac is and what it is used for
• 2. What you need to know before you take Temomedac
• 3. How to take Temomedac
• 4. Possible side effects
• 5. How to store Temomedac
• 6. Contents of the pack and other information

1. What is Temomedac and what is it used for

Temomedac contains a medicine called temozolomide. This medicine is an antitumor agent.
Temomedac is used for the treatment of specific forms of brain tumor:

• in adults with newly diagnosed glioblastoma multiforme. Temomedac is initially used in association with radiotherapy (concomitant treatment phase) and subsequently alone (monotherapy treatment phase).
• in children aged 3 years and older and in adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma. Temomedac is used in these tumors that manifest relapse or progression after standard therapy.

2. What you need to know before taking Temomedac

Do not take Temomedac

• if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6).
• if you have had a previous allergic reaction to dacarbazine (an anti-cancer medicine, sometimes called DTIC). Signs of an allergic reaction include itching, shortness of breath or wheezing, swelling of the face, lips, tongue or throat.
• if the number of certain types of blood cells is severely reduced (myelosuppression), such as white blood cells and platelets. These blood cells are important for fighting infections and for proper blood clotting. The doctor will have you undergo

blood tests to make sure that the number of these cells is sufficient to start the
treatment.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Temomedac,

• because you must be carefully monitored for the development of a severe form of chest infection called Pneumocystis jiroveciipneumonia (PCP). If you are a newly diagnosed patient (glioblastoma multiforme) you may be given Temomedac for 42 days in combination with radiotherapy. In this case, the doctor will also prescribe you medicines to help prevent this type of pneumonia (PCP).
• if you have ever had or currently have an infection with hepatitis B. This is because Temomedac may cause a reactivation of hepatitis B, which in some cases can be fatal. Before starting treatment, patients will be carefully checked by the doctor to see if there are signs of this infection.
• if you have a low number of red blood cells (anemia), white blood cells and platelets, or blood clotting problems before the start of treatment, or if you develop them during treatment. The doctor may decide to reduce the dose, interrupt, suspend or change the treatment. You may also need other treatments. In some cases, it may be necessary to stop giving Temomedac.
• samples of your blood will be analyzed frequently during treatment to check for side effects of Temomedac on your blood cells.
• because you may be at low risk of developing other blood cell changes, including leukemia.
• if you have nausea (feeling sick to the stomach) and/or vomiting, which are very common side effects of Temomedac (see section 4), the doctor may prescribe you a medicine (an anti-emetic) to help prevent vomiting. If you vomit frequently before or during treatment, ask your doctor for the best time to take Temomedac until the vomiting is under control. If you vomit after taking a dose, do not take a second dose on the same day.
• if you develop a fever or symptoms of an infection, contact your doctor immediately.
• if you are over 70 years of age, you may be more prone to infections, bruising or bleeding.
• if you have liver or kidney problems, your dose of Temomedac may need to be adjusted.

Children and adolescents
Do not give this medicine to children under the age of 3 years because it has not been studied. There are
limited data in patients over 3 years of age who have taken Temomedac.

Other medicines and Temomedac
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, ask your doctor
or pharmacist for advice before taking this medicine. This is because you should not be treated with
Temomedac during pregnancy unless clearly indicated by your doctor.
Effective contraceptive precautions must be taken by women of childbearing potential during treatment with Temomedac and for at least 6 months after completion of
treatment.
You must stop breastfeeding if you are being treated with Temomedac.

Male fertility
Temomedac may cause permanent infertility. Men must use effective contraception and not try to father a child for at least 3 months after stopping treatment.
It is recommended to inquire about sperm preservation before starting treatment.

Driving and using machines
Temomedac may cause fatigue or drowsiness. If this happens, do not drive or use tools or
machinery or ride a bicycle until you see how this medicine affects you (see
section 4).

Temomedac contains lactose
Temomedac contains lactose (a type of sugar). If your doctor has told you that you have an intolerance
to certain sugars, contact him before taking this medicine.

Temomedac contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule, i.e. essentially
‘sodium-free’.

Additional information for Temomedac 20 mg hard capsules
The sunset yellow FCF (E 110) excipient in the capsule shell may cause allergic
reactions.

3. How to take Temomedac

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Dosage and duration of treatment
The doctor will determine your dose of Temomedac. This depends on your size (height and weight) and, if
you have a recurrent tumor, on any previous chemotherapy treatment.
Other medicines (anti-emetics) may be prescribed to be taken before and/or after taking
Temomedac to prevent or control nausea and vomiting.

Patients with newly diagnosed glioblastoma multiforme
If you are a patient who has been diagnosed with the tumor for the first time, treatment will take place in two
phases:

• initially Temomedac is combined with radiotherapy (concomitant phase)
• subsequently Temomedac is administered alone (monotherapy phase). During the concomitant phase, the doctor will start Temomedac at a dose of 75 mg/m (usual dose). You will take this dose every day for 42 days (up to a maximum of 49 days) in combination with radiotherapy. Taking the dose of Temomedac may be delayed or interrupted based on the number of your blood cells and how you tolerate the medicine during the concomitant phase. Once radiotherapy is completed, you will interrupt treatment for 4 weeks. This will give your body the chance to recover. Then, you will start monotherapy.

During the monotherapy phase, the dose and how to take Temomedac will be different. The
doctor will establish your correct dose. There may be up to 6 treatment periods (cycles).
Each one lasts 28 days. You will take your new dose of Temomedac alone once a day
for the first 5 days (“therapy days”) of each cycle. The first dose will be 150 mg/m . Then
will follow 23 days without Temomedac. This achieves the 28 days of the treatment cycle.
After Day 28, you will start the next cycle. You will still take Temomedac once a day
for 5 days followed by 23 days without Temomedac. The dose of Temomedac may be adjusted,
delayed or interrupted based on your blood count and how you tolerate the medicine during
each treatment cycle.

Patients with tumors that have recurred or worsened (malignant gliomas, such as glioblastoma

multiforme or anaplastic astrocytoma) treated with Temomedac alone
A treatment cycle with Temomedac lasts 28 days.
You will take Temomedac alone once a day for the first 5 days. This daily dose
depends on any previous chemotherapy treatments.
If you have not been previously treated with chemotherapy, your first dose of Temomedac will be
200 mg/m once a day for the first 5 days. If you have been treated previously with
chemotherapy, your first dose of Temomedac will be 150 mg/m once a day for the first
5 days.
For the next 23 days you will no longer receive Temomedac. This completes the 28-day cycle.
After Day 28, you will begin the next cycle. You will take Temomedac again once a day
for five days, followed by 23 days without Temomedac.
Before each new cycle, you will have blood tests to verify whether the dose of
Temomedac needs to be modified. Based on the results of your blood tests, the doctor may
modify your dose for the next cycle.
How to take Temomedac
Take the dose of Temomedac that has been prescribed to you once a day, preferably every
day at the same time .
Take the capsules on an empty stomach; for example, at least one hour before breakfast. Swallow
the capsule(s) whole with a glass of water. Do not open, crush or chew the capsules. If the
capsule is damaged, avoid contact of the powder with skin, eyes or nose. If
accidentally some powder should come into contact with the eyes or nose, rinse with
water the affected area.

Depending on the prescribed dose, you may need to take more than one capsule
at a time, possibly with different dosages (content of the active substance in mg). The
color and the figure on the capsule shell are different for each dosage (see the table
below).
It is necessary to make sure you understand well and remember the following:

• how many capsules you need to take for your daily dosage. Ask your doctor or pharmacist to write it down for you (including the color).
• what are the days of taking the therapy. Review the dose with your doctor each time you have to start a new cycle, as it may be different from the previous cycle.

Take Temomedac following exactly the instructions of your doctor. If you have any doubts, consult
your doctor or pharmacist. Errors in taking this medicine could cause serious damage
to your health.

If you take more Temomedac than you should
In the event of accidental taking a number of capsules greater than prescribed, contact
immediately your doctor, pharmacist or nurse.

If you forget to take Temomedac
Take the dose you forgot as soon as possible during the same day. If a whole
day has passed, contact your doctor. Do not take a double dose to make up for the forgotten
dose, unless you are told to do so by your doctor.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediatelyif you experience:

• a severe allergic reaction (hypersensitivity) (urticaria, wheezing or other breathing difficulties),
• uncontrolled bleeding,
• convulsions (seizures),
• fever,
• chills,
• severe headache that does not go away.

Treatment with Temomedac may cause a decrease in certain types of blood cells. This may
lead to increased bruising or bleeding, anemia (reduced number of red blood cells), fever and a
reduced resistance to infections. The decrease in the number of blood cells is usually temporary.
In some cases, it may be prolonged and may lead to a very serious form of anemia
(aplastic anemia). Your doctor will regularly monitor your blood and decide if
specific therapy is necessary. In some cases, the dose of Temomedac will be reduced or the treatment
terminated.
Other side effects that have been reported are listed below:

Very common side effects (may affect more than 1 in 10 people):

• loss of appetite, difficulty speaking, headache
• vomiting, nausea, diarrhea, constipation
• skin rash, hair loss
• fatigue

Common side effects (may affect up to 1 in 10 people):

• infections, mouth infections
• decreased number of blood cells (neutropenia, lymphopenia, thrombocytopenia)
• allergic reaction
• increased blood sugar
• memory loss, depression, anxiety, confusion, inability to fall asleep or stay asleep
• coordination disorders and balance problems
• difficulty concentrating, altered mental status or attention, memory loss
• dizziness, sensory disturbance, tingling, tremor, altered taste
• partial vision loss, abnormal vision, double vision, eye pain
• deafness, ringing in the ears, ear pain
• blood clots in the lung or legs, high blood pressure
• pneumonia, shortness of breath, bronchitis, cough, inflammation of the nasal cavities
• stomach or abdominal pain, stomach disorders/heartburn, difficulty swallowing
• dry skin, itching
• muscle damage, muscle weakness, muscle pain and cramps
• joint pain, back pain
• frequent urination, difficulty holding urine
• fever, flu-like symptoms, pain, feeling unwell, cold or flu
• fluid retention, swollen legs
• increased liver enzymes
• weight loss, weight gain
• radiation injury

Uncommon side effects (may affect up to 1 in 100 people):

• brain infections (herpes meningoencephalitis) including cases that have been fatal
• new or reactivated infections from cytomegalovirus
• wound infections
• infections caused by reactivated hepatitis B virus
• secondary tumors including leukemia
• decreased number of blood cells (pancytopenia, anemia, leucopenia)
• red spots under the skin
• diabetes insipidus (symptoms include increased urine output and feeling thirsty), low potassium level in the blood
• mood changes, hallucination
• partial paralysis, change in the perception of smells
• dry eyes
• hearing disorders, middle ear infection
• palpitations (when you can feel your heartbeat), hot flushes
• swollen stomach, difficulty controlling bowel movements, hemorrhoids, dry mouth
• hepatitis and liver damage (including liver failure leading to death), cholestasis, increased bilirubin
• blisters on the body or in the mouth, skin peeling, painful red skin, severe rash with swelling of the skin (including palms of hands and soles of feet)
• increased skin sensitivity to sunlight, urticaria (hives), increased sweating, change in skin color
• difficulty urinating
• vaginal bleeding, vaginal irritation, absent or heavy menstrual periods, breast pain, sexual impotence
• chills, facial swelling, tongue discoloration, thirst, dental disorders

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system
indicated in Annex V. By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Temomedac

Keep this medicine out of the sight and reach of children, preferably in a locked cabinet. Accidental ingestion may cause death in children.
Do not use this medicine after the expiry date which is stated on the label and the packaging. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Store in the original package to protect the medicine from moisture.
Keep the bottle tightly closed.
Inform your pharmacist if you notice any changes in the appearance of the capsules.
Medicines should not be disposed of via drains or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Do not dispose of any medicine via drains or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Temomedac contains

• The active ingredient is temozolomide. Temomedac 5 mg hard capsules:Each capsule contains 5 mg of temozolomide. Temomedac 20 mg hard capsules:Each capsule contains 20 mg of temozolomide. Temomedac 100 mg hard capsules:Each capsule contains 100 mg of temozolomide. Temomedac 140 mg hard capsules:Each capsule contains 140 mg of temozolomide. Temomedac 180 mg hard capsules:Each capsule contains 180 mg of temozolomide. Temomedac 250 mg hard capsules:Each capsule contains 250 mg of temozolomide.
• The other ingredients are: capsule content: anhydrous lactose, anhydrous colloidal silicon dioxide, sodium carboxymethylcellulose type A, tartaric acid, stearic acid (see section 2 "Temomedac contains lactose"). capsule shell (including printing ink): Temomedac 5 mg hard capsules:gelatin, titanium dioxide (E 171), shellac, glycol propylene, aluminum lake cochineal carmine (E 132), yellow iron oxide (E 132). Temomedac 20 mg hard capsules:gelatin, titanium dioxide (E 171), shellac, glycol propylene, aluminum lake sunset yellow FCF (E 110). Temomedac 100 mg hard capsules:gelatin, titanium dioxide (E 171), red iron oxide (E 172), shellac, glycol propylene and yellow iron oxide (E 172). Temomedac 140 mg hard capsules:gelatin, titanium dioxide (E 171), shellac, glycol propylene, aluminum lake indigo carmine (E 132). Temomedac 180 mg hard capsules:gelatin, titanium dioxide (E 171), shellac, glycol propylene, red iron oxide (E 172). Temomedac 250 mg hard capsules:gelatin, titanium dioxide (E 171), shellac, glycol propylene, black iron oxide (E 172).

Description of the appearance of Temomedac and contents of the pack

Temomedac 5 mg hard capsuleshave an opaque white body, a cap with two lines of
green ink and “T 5 mg” is printed on the capsule body in green ink.

Temomedac 20 mg hard capsuleshave an opaque white body, a cap with two lines of
orange ink and “T 20 mg” is printed on the capsule body in orange ink.

Temomedac 100 mg hard capsuleshave an opaque white body, a cap with two lines of
pink ink and “T 100 mg” is printed on the capsule body in pink ink.

Temomedac 140 mg hard capsuleshave an opaque white body, a cap with two lines of
blue ink and “T 140 mg” is printed on the capsule body in blue ink.

Temomedac 180 mg hard capsuleshave an opaque white body, a cap with two lines of
red ink and “T 180 mg” is printed on the capsule body in red ink.

Temomedac 250 mg hard capsuleshave an opaque white body, a cap with two lines of
black ink and “T 250 mg” is printed on the capsule body in black ink.
The hard capsules for oral use are supplied in amber-colored glass bottles containing 5 or 20 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
medac
Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany

Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .